|
4 PIPELINE UPDATE - ASTRAZENECA DEVELOPMENT PIPELINE,
|
|
30 JUNE 2014
|
|
Compound
|
Mechanism
|
Area Under Investigation
|
Date Commenced Phase
|
Estimated Filing
|
|||
|
US
|
EU
|
Japan
|
China
|
||||
|
Cardiovascular
and Metabolism
|
|||||||
|
Brilinta / Brilique1
|
ADP receptor antagonist
|
arterial thrombosis
|
Launched
|
Launched
|
Filed
|
Launched
|
|
|
Epanova#
|
omega-3 free fatty acids
|
hypertriglyceridaemia
|
Approved
|
||||
|
Farxiga / Forxiga2
|
SGLT-2 inhibitor
|
diabetes
|
Launched
|
Launched
|
Launched
|
Filed
|
|
|
Myalept
|
leptin analogue
|
lipodystrophy
|
Launched
|
2015
|
N/A
|
||
|
roxadustat#
|
hypoxia-inducible factor inhibitor
|
anaemia in CKD / ESRD
|
Q3 20143
|
2018
|
N/A
|
N/A
|
2016
|
|
Oncology
|
|||||||
|
AZD9291¶
|
EGFR tyrosine kinase inhibitor
|
advanced T790M+ NSCLC
|
Q2 2014
|
2015
|
2015
|
2015
|
2017
|
|
Caprelsa
|
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
|
medullary thyroid cancer
|
Launched
|
Launched
|
Q3 2014
|
Filed
|
|
|
MEDI4736#
PACIFIC
|
anti-PD-L1 MAb
|
stage III NSCLC
|
Q2 2014
|
2017
|
2020
|
2020
|
|
|
MEDI4736#
ATLANTIC¶
|
anti-PD-L1 MAb
|
3rd line NSCLC
|
Q1 2014
|
2016
|
2017
|
2017
|
|
|
moxetumomab pasudotox#
|
anti-CD22 recombinant
immunotoxin
|
hairy cell leukaemia
|
Q2 2013
|
2018
|
2018
|
||
|
olaparib
|
PARP inhibitor
|
BRCAm PSR ovarian cancer
|
Filed
|
Filed
|
|||
|
olaparib SOLO-1
|
PARP inhibitor
|
1st line BRCAm ovarian cancer
|
Q3 2013
|
2017
|
2017
|
2017
|
2018
|
|
olaparib SOLO-2
|
PARP inhibitor
|
BRCAm PSR ovarian cancer
|
Q3 2013
|
2016
|
2016
|
2016
|
2016
|
|
olaparib GOLD
|
PARP inhibitor
|
2nd line gastric cancer
|
Q3 2013
|
2017
|
2018
|
||
|
olaparib OlympiA
|
PARP Inhibitor
|
adjuvant breast cancer
|
Q2 2014
|
2020
|
2020
|
2020
|
2021
|
|
olaparib OlympiAD
|
PARP inhibitor
|
metastatic breast cancer
|
Q2 2014
|
2016
|
2016
|
2016
|
|
|
selumetinib#
SELECT-1
|
MEK inhibitor
|
2nd line KRAS+ NSCLC
|
Q4 2013
|
2017
|
2017
|
||
|
selumetinib#
ASTRA
|
MEK inhibitor
|
differentiated thyroid cancer
|
Q3 2013
|
2017
|
2017
|
||
|
selumetinib#
SUMIT
|
MEK inhibitor
|
uveal melanoma
|
Q2 2014
|
2015
|
2015
|
||
|
tremelimumab¶
|
anti-CTLA-4 MAb
|
mesothelioma
|
Q2 2014
|
2017
|
2017
|
2017
|
|
|
Compound
|
Mechanism
|
Area Under Investigation
|
Date Commenced Phase
|
Estimated Filing
|
|||
|
US
|
EU
|
Japan
|
China
|
||||
|
Respiratory, Inflammation and Autoimmunity
|
|||||||
|
benralizumab#
CALIMA, SIROCCO, ZONDIA
|
anti-IL-5R MAb
|
severe asthma
|
Q4 2013
|
2016
|
2016
|
||
|
benralizumab#
TERRANOVA, GALATHEA
|
anti-IL-5R MAb
|
COPD
|
Q3 20144
|
2018
|
2018
|
||
|
brodalumab#
AMAGINE-1,2,3
|
anti-IL-17R MAb
|
psoriasis
|
Q3 2012
|
++
|
++
|
||
|
brodalumab# AMVISION-1,2
|
anti-IL-17R MAb
|
psoriatic arthritis
|
Q1 2014
|
++
|
++
|
||
|
lesinurad
|
selective uric acid reabsorption inhibitor (URAT1)
|
chronic treatment of patients with gout
|
Q4 2011
|
Q4 2014
|
Q4 2014
|
n/a5
|
|
|
PT003 GFF
|
LAMA / LABA
|
COPD
|
Q2 2013
|
2015
|
2016
|
||
|
PT001 GP
|
LAMA
|
COPD
|
Q2 2013
|
2015
|
2016
|
||
|
Infection
|
|||||||
|
CAZ AVI# RECLAIM
|
cephalosporin / beta lactamase inhibitor
|
serious infections
|
Q1 2012
|
N/A
|
Q4 2014
|
2015
|
2016
|
|
CAZ AVI# REPROVE
|
cephalosporin / beta lactamase inhibitor
|
hospital-acquired pneumonia / ventilator-associated pneumonia
|
Q2 2013
|
N/A
|
2017
|
2017
|
2018
|
|
Zinforo#
|
extended spectrum cephalosporin with affinity to penicillin-binding proteins
|
pneumonia / skin infections
|
N/A
|
Launched
|
N/A
|
Filed
|
|
|
Neuroscience
|
|||||||
|
Movantik#
|
oral peripherally-acting mu-opioid receptor antagonist
|
opioid-induced constipation
|
Filed
|
Filed
|
|||
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Date Commenced Phase
|
Estimated Filing
|
|||
|
US
|
EU
|
Japan
|
China
|
|||||
|
Cardiovascular and Metabolism
|
||||||||
|
tenapanor (AZD1722)#
|
NHE3 inhibitor
|
ESRD-Pi / CKD with T2DM1
|
II
|
Q1 2013
|
||||
|
AZD4901
|
hormone modulator
|
polycystic ovarian syndrome
|
II
|
Q2 2013
|
||||
|
AZD1979
|
melanin-concentrating hormone (MCH) receptor
|
obesity
|
I
|
Q2 2014
|
||||
|
MEDI6012
|
LCAT
|
arterial thrombosis
|
I
|
Q1 2012
|
||||
|
MEDI8111
|
Rh-factor II
|
trauma / bleeding
|
I
|
Q1 2014
|
||||
|
Oncology
|
||||||||
|
AZD1775#
|
WEE-1 inhibitor
|
ovarian cancer
|
II
|
Q4 2012
|
||||
|
AZD2014
|
mTOR serine / threonine kinase inhibitor
|
solid tumours
|
II
|
Q1 2013
|
||||
|
AZD4547
|
FGFR tyrosine kinase inhibitor
|
solid tumours
|
II
|
Q4 2011
|
||||
|
MEDI-551#
|
anti-CD19 MAb
|
CLL / DLBCL
|
II
|
Q1 2012
|
||||
|
MEDI-573#
|
anti-IGF MAb
|
metastatic breast cancer
|
II
|
Q2 2012
|
||||
|
selumetinib#
|
MEK inhibitor
|
2nd line KRAS- NSCLC
|
II
|
Q1 2013
|
||||
|
AZD5363#
|
AKT kinase inhibitor
|
breast cancer
|
II
|
Q1 2014
|
||||
|
volitinib#
|
MET tyrosine kinase inhibitor
|
papillary renal cell carcinoma
|
II
|
Q2 2014
|
||||
|
AZD1208
|
PIM kinase inhibitor
|
haematological malignancies
|
I
|
Q1 2012
|
||||
|
AZD5312#
|
androgen receptor inhibitor
|
prostate cancer
|
I
|
Q2 2014
|
||||
|
AZD6738
|
ATR serine / threonine kinase inhibitor
|
CLL / head & neck
|
I
|
Q4 2013
|
||||
|
AZD8186
|
PI3 kinase beta inhibitor
|
solid tumours
|
I
|
Q2 2013
|
||||
|
AZD9150#
|
STAT3 inhibitor
|
haematological malignancies
|
I
|
Q1 2012
|
||||
|
MEDI-565#
|
anti-CEA BiTE MAb
|
solid tumours
|
I
|
Q1 2011
|
||||
|
MEDI0639#
|
anti-DLL-4 MAb
|
solid tumours
|
I
|
Q2 2012
|
||||
|
MEDI0680
|
anti-PD-1 MAb
|
solid tumours
|
I
|
Q4 2013
|
||||
|
MEDI3617#
|
anti-ANG-2 MAb
|
solid tumours
|
I
|
Q4 2010
|
||||
|
MEDI4736# + tremelimumab
|
anti-PD-L1 MAb + anti-CTLA-4 MAb
|
solid tumors
|
I
|
Q4 2013
|
||||
|
MEDI4736# + dabrafenib + trametinib2
|
anti-PD-L1 MAb + BRAF inhibitor + MEK inhibitor
|
melanoma
|
I
|
Q1 2014
|
||||
|
MEDI4736# +
Iressa
|
anti-PD-L1 MAb + EGFR inhibitor
|
NSCLC
|
I
|
Q2 2014
|
||||
|
MEDI4736# + MEDI0680
|
anti-PD-L1 MAb + anti-PD-1 MAb
|
solid tumours
|
I
|
Q2 2014
|
||||
|
MEDI-551# + rituximab3
|
anti-CD19 MAb + anti-CD20 MAb
|
haematological malignancies
|
I
|
Q2 2014
|
||||
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Date Commenced Phase
|
Estimated Filing
|
|||
|
US
|
EU
|
Japan
|
China
|
|||||
|
Oncology (continued)
|
||||||||
|
MEDI6469#
|
murine anti-OX40 MAb
|
solid tumours
|
I
|
Q1 2006
|
||||
|
moxetumomab
pasudotox#
|
anti-CD22 recombinant immunotoxin
|
pALL
|
I
|
Q3 2008
|
||||
|
tremelimumab +
Iressa
|
anti-CTLA-4 MAb + EGFR inhibitor
|
NSCLC
|
I
|
Q2 2014
|
||||
|
Respiratory, Inflammation and Autoimmunity
|
||||||||
|
AZD2115#
|
MABA
|
COPD
|
II
|
Q2 2012
|
||||
|
AZD9412# (SNG001)
|
inhaled interferon β
|
asthma / COPD
|
II
|
Q1 2010
|
||||
|
anifrolumab#
|
anti-IFN-alphaR MAb
|
SLE
|
II
|
Q1 2012
|
||||
|
brodalumab#
|
anti-IL-17R MAb
|
asthma
|
II
|
Q2 2013
|
||||
|
mavrilimumab#
|
anti-GM-CSFR MAb
|
rheumatoid arthritis
|
II
|
Q1 2010
|
||||
|
MEDI2070#
|
anti-IL-23 MAb
|
Crohn's disease
|
II
|
Q1 2013
|
||||
|
MEDI7183#
|
anti-a4b7 MAb
|
Crohn's disease / ulcerative colitis
|
II
|
Q4 2012
|
||||
|
MEDI9929#
|
anti-TSLP MAb
|
asthma
|
II
|
Q2 2014
|
||||
|
PT010
|
LAMA / LABA / ICS
|
COPD
|
II
|
Q2 2014
|
||||
|
RDEA3170
|
selective uric acid reabsorption inhibitor (URAT1)
|
chronic management of hyperuricaemia in patients with gout
|
II
|
Q3 2013
|
||||
|
sifalimumab#
|
anti-IFN-alpha MAb
|
SLE
|
II
|
Q3 2008
|
||||
|
tralokinumab
|
anti-IL-13 MAb
|
asthma / IPF
|
II
|
Q1 2008
|
||||
|
AZD1419#
|
TLR9 agonist
|
asthma
|
I
|
Q3 2013
|
||||
|
AZD7594
|
inhaled SGRM
|
asthma / COPD
|
I
|
Q3 20124
|
||||
|
AZD7624
|
inhaled P38 inhibitor
|
COPD
|
I
|
Q1 2013
|
||||
|
AZD8848#
|
inhaled TLR7 agonist
|
asthma
|
I
|
Q2 2012
|
||||
|
MEDI-551#
|
anti-CD19 MAb
|
multiple sclerosis
|
I
|
Q3 2012
|
||||
|
MEDI4920
|
anti-CD40L MAb
|
primary Sjögren's syndrome
|
I
|
Q2 2014
|
||||
|
MEDI5872#
|
anti-B7RP1 MAb
|
SLE
|
I
|
Q4 2008
|
||||
|
Infection
|
||||||||
|
AZD5847
|
oxazolidinone anti-bacterial inhibitor
|
tuberculosis
|
II
|
Q4 2012
|
||||
|
CXL#
|
beta lactamase inhibitor / cephalosporin
|
MRSA
|
II
|
Q4 2010
|
||||
|
ATM AVI
|
monobactam / beta lactamase inhibitor
|
targeted serious bacterial infections
|
I
|
Q4 2012
|
||||
|
AZD0914
|
GyrAR
|
serious bacterial infections
|
I
|
Q4 2013
|
||||
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Date Commenced Phase
|
Estimated Filing
|
||||
|
US
|
EU
|
Japan
|
China
|
||||||
|
Infection (continued)
|
|||||||||
|
MEDI-550
|
pandemic influenza virus vaccine
|
pandemic influenza prophylaxis
|
I
|
Q2 2006
|
|||||
|
MEDI-559
|
paediatric RSV vaccine
|
RSV prophylaxis
|
I
|
Q4 2008
|
|||||
|
MEDI4893
|
MAb binding to S. aureus
toxin
|
hospital-acquired pneumonia / serious
S. aureus
infection
|
I
|
Q1 2013
|
|||||
|
MEDI7510
|
RSV sF+GLA-SE
|
prevention of RSV disease in older adults
|
I
|
Q2 2014
|
|||||
|
MEDI8897#
|
anti-RSV MAb-YTE
|
passive RSV prophylaxis
|
I
|
Q2 2014
|
|||||
|
Neuroscience
|
|||||||||
|
AZD3241
|
myeloperoxidase inhibitor
|
multiple system atrophy5
|
II
|
Q2 2012
|
|||||
|
AZD5213
|
histamine-3 receptor antagonist
|
Tourette's syndrome / neuropathic pain
|
II
|
Q4 2013
|
|||||
|
AZD3293#
|
beta-secretase inhibitor
|
Alzheimer's disease
|
I
|
Q4 2012
|
|||||
|
AZD6423
|
NMDA antagonist
|
suicidal ideation
|
I
|
Q3 2013
|
|||||
|
MEDI1814
|
anti-amyloid beta MAb
|
Alzheimer's disease
|
I
|
Q2 2014
|
|||||
|
Compound
|
Mechanism
|
Area Under Investigation
|
Date Commenced Phase
|
Estimated Filing
|
|||
|
US
|
EU
|
Japan
|
China
|
||||
|
Cardiovascular and Metabolism
|
|||||||
|
Brilinta/ Brilique1 EUCLID
|
ADP receptor antagonist
|
outcomes study in patients with peripheral artery disease
|
Q4 2012
|
2016
|
2016
|
2017
|
2017
|
|
Brilinta/ Brilique1
PEGASUS-TIMI 54
|
ADP receptor antagonist
|
outcomes study in patients with prior myocardial infarction
|
Q4 2010
|
2015
|
2015
|
2015
|
2017
|
|
Brilinta/ Brilique1 SOCRATES
|
ADP receptor antagonist
|
outcomes study in patients with stroke or TIA
|
Q1 2014
|
2016
|
2016
|
2016
|
2017
|
|
Brilinta/ Brilique1 THEMIS
|
ADP receptor antagonist
|
outcomes study in patients with Type 2 diabetes and CAD, but without a previous history of MI or stroke
|
Q1 2014
|
2017
|
2017
|
2018
|
2018
|
|
BydureonDual Chamber Pen
|
GLP-1 receptor agonist
|
diabetes
|
Approved
|
Filed
|
Filed
|
||
|
BydureonEXSCEL
|
GLP-1 receptor agonist
|
outcomes study
|
Q2 2010
|
2018
|
2018
|
2018
|
|
|
Bydureonweekly
suspension
|
GLP-1 receptor agonist
|
diabetes
|
Q1 2013
|
2015
|
2015
|
||
|
Farxiga/ Forxiga2
DECLARE-TIMI 58
|
SGLT-2 inhibitor
|
outcomes study
|
Q2 2013
|
2020
|
2020
|
||
|
KombiglyzeXRFDC /
KomboglyzeFDC3
|
DPP-4 inhibitor / metformin FDC
|
diabetes
|
Launched
|
Launched
|
Filed
|
||
|
OnglyzaSAVOR-TIMI 53
|
DPP-4 inhibitor
|
outcomes study
|
Q2 2010
|
Filed
|
Filed
|
2015
|
|
|
saxagliptin / dapagliflozin FDC
|
DPP-4 inhibitor / SGLT-2 inhibitor FDC
|
diabetes
|
Q2 2012
|
2015
|
2015
|
||
|
XigduoXRFDC /Xigduo
FDC4
|
SGLT-2 inhibitor / metformin FDC
|
diabetes
|
Filed
|
Launched
|
|||
|
Oncology
|
|||||||
|
Caprelsa
|
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
|
differentiated thyroid cancer
|
Q2 2013
|
2016
|
2016
|
2016
|
|
|
FaslodexFALCON
|
oestrogen receptor antagonist
|
1st line advanced breast cancer
|
Q4 2012
|
2016
|
2016
|
2016
|
2016
|
|
IressaIMPRESS
|
EGFR tyrosine kinase inhibitor
|
treatment beyond progression
|
Q1 2012
|
2015
|
2015
|
2015
|
|
|
Respiratory, Inflammation and Autoimmunity
|
|||||||
|
Symbicort5
|
ICS / LABA
|
Breath Actuated Inhaler asthma / COPD
|
|||||
|
Compound
|
Mechanism
|
Area Under Investigation
|
Date Commenced Phase
|
Estimated Filing
|
|||
|
US
|
EU
|
Japan
|
China
|
||||
|
Neuroscience
|
|||||||
|
Diprivan#
|
sedative and anaesthetic
|
conscious sedation
|
N/A
|
Launched
|
Q4 2014
|
Launched
|
|
|
Gastrointestinal
|
|||||||
|
Entocort
|
glucocorticoid steroid
|
Crohn's disease / ulcerative colitis
|
Launched
|
Launched
|
2015
|
N/A
|
|
|
linaclotide#
|
GC-C receptor peptide agonist
|
irritable bowel syndrome with constipation
(IBS-C)
|
N/A
|
N/A
|
N/A
|
2015
|
|
|
Nexium
|
proton pump inhibitor
|
peptic ulcer bleeding
|
Launched
|
Launched
|
N/A
|
Launched
|
|
|
NME / Line Extension
|
Compound
|
Reason for Discontinuation
|
Area Under Investigation
|
|
NME
|
AZD47211
|
Safety / efficacy
|
COPD
|
|
NME
|
AZD50691
|
Safety / efficacy
|
asthma
|
|
NME
|
MEDI8968#
|
Safety / efficacy
|
COPD / HS
|
|
NME
|
MEDI9287
|
economic
|
avian influenza
|
|
Date: 31 July 2014
|
By: /s/ Adrian Kemp
|
|
Name: Adrian Kemp
|
|
|
Title: Company Secretary
|